Home Reported Outcomes in C3G Study
A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in C3 Glomerulopathy (C3G) in the US
Novartis Pharmaceuticals
100 participants
Apr 7, 2025
OBSERVATIONAL
Conditions
Summary
The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall Health-related Quality of Life (HRQoL) experienced by C3 glomerulopathy (C3G) patients and their caregivers. By primarily utilizing home reported outcomes (HRO) data on symptom burden and treatment usage, supplemented with patient-reported outcome (PRO) measures (collected at baseline and monthly), the study seeks to establish a new real-world data (RWD) source to understand symptom variability and HRQoL as reported by C3G patients and caregivers, including those taking iptacopan
Eligibility
Inclusion Criteria8
- Eligible participants will meet the following basic criteria:
- Clinical diagnosis of C3G, regardless of symptom, treatment, or transplant history
- Adult aged 18 or older; adult caregiver to an adult patient aged 18 or older; or adult caregiver to a pediatric patient under 18 years of age
- Able to provide informed consent
- Has access to technology (i.e. mobile phone, tablet) that facilitates their participation in the app-based study
- US-based with a proficient understanding of and ability to read the English language
- The study team will aim to enroll and collect data on participants who are taking any form of treatment. Participants may be asked to recall the start date of taking their current therapy.
- Diagnosis of C3G will be confirmed through self-reported screening procedures, patient-supplied documentation, and/or successful linkage of the patient's data with their record in a Novartis data platform. Confirmation of diagnosis for each participant will be reviewed by the Folia Health study team as part of standard validation procedures.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07029542